Soft silicon edged cushion for face masks

ABSTRACT

A soft medical silicone edged cushion may significantly reduce air leakage and provide comfort to a wearer of a face mask, for example, when the face mask is continually worn by a healthcare worker for a twelve hour shift of medical duty. The cushion may preferably be U-shaped and comprise a cross-section for holding an extra soft silicone gel, yet be sufficiently hard and elastic and of predetermined circumference to be adaptable to self-installation to the lateral edges of a face mask and coatable to protect from the escape of air and to fit comfortably despite the use of elastic straps with the face mask or the presence of solid plastic lateral edges of an oxygen mask or a ventilator mask. The cushion may be used to cushion a solid plastic laterally edged oxygen or ventilator mask against the use of elastic ties to tie the face mask around a patient&#39;s head.

This application claims the benefit of priority to U.S. ProvisionalPatent Application Ser. No. 63/027,208 filed May 19, 2020, entitled“Soft Silicon Edged Cushion for Face Masks,” by the same inventor.

FIELD OF THE INVENTION

The present invention generally relates to the technical field ofapparatus and a method for protecting the face of a healthcare worker, apatient requiring use of a ventilator or an oxygen mask, a surgeondesirous of a safe and comfortable surgical mask, or emergency technicalpersonnel requiring protection from damage during prolonged use of aface mask and, more particularly, to apparatus comprising asemicircular, flexible U-shaped or mostly circular cross-section oftubing or a shell comprising a soft silicone edged cushion that may holda soft medical gel or jelly material or permit the soft gel material tocoat both the tubing or shell and a cloth surface or protect a lateraledge of the face mask so as to protect a user from facial damage ordiscomfort.

BACKGROUND OF THE INVENTION

CNN interviewed Dr. Sanjay Gupta, medical advisor to CNN, on Jul. 24,2020. During the CNN interview, Gupta is quoted as saying: “We'rebasically told to reuse the same mask as long as we can.” In answer to aquestion of an interviewer, Dr. Gupta stated: “So the mask, just notthat this matters as much, but you're wearing this mask doing a five,six hour operation. If you're wearing it properly with a fit test, itdigs into your face. It hurts after a while. But you do everything toprotect it; it's like gold. So I'll wear another mask on top of it, toprevent that N95 mask from being contaminated.”

Across the United States and internationally, local, state and federalgovernments are recommending the use of social distancing and relatedface masks to safeguard from a pandemic related to corona virus orCovid-19. Despite weeks of conflicting, and often confusing informationon the effectiveness of face masks of all types for public use, theCenter for Disease Control and Prevention (CDC) recommends that everyonewear face masks. A face mask may be defined for the purposes of thispatent application as any variation of a mask that is intended to coverthe mouth and nose to protect against inhalation or other exposure tovirus pathogens. The face mask may be a surgical mask, a mask of hardrubber or plastic material (for example, an oxygen mask or a ventilatormask), a cloth mask produced from several layers of a cloth material.One or more layers may be capable of bonding to and holding incomingpathogens and the like preventing them from being inhaled. According tothe CDC, “cloth face coverings should: fit snugly but comfortablyagainst the side of the face; be secured with ties or ear loops; includemultiple layers of fabric; and allow for breathing without restriction.”In particular, cloth masks are recommended for general use and surgicalmasks and N95 respirators manufactured, for example, by 3M since 1972are recommended for use by healthcare workers. The N in N95 denotes arating that does not protect against oil-based aerosols but is highlyrecommended for use by healthcare workers. The 95 represents the percentof 0.3 micron particles removed from air that is inhaled through theface mask.

Hospitals have also used oxygen masks or ventilators to deliverpathogen-tree oxygen through the nose in acute or intensive care units.For the present purposes, an oxygen mask or a ventilator may causeproblems with comfort of the mask/ventilator, and such an oxygen mask orventilator device is encompassed by the present patent application.

People who go to public places such as grocery stores may weardisposable cloth masks while healthcare workers may, for example, useN95 respirators and surgical masks. Whether one is a member of thepublic or a healthcare worker, a mask should completely cover the mouthand nose and preclude the admission of air through gaps in the clothcaused by inappropriate use of a cloth mask or the rigidity of a maskmade from solid material such as a ventilator or oxygen mask. At thesame time, masks (as opposed to handkerchiefs, bandanas and make-shiftface masks) should be avoided because air and liquid droplets ofpathogens may not be absorbed by the single layer of cloth and may entervia the chin or other unprotected areas of the face.

The general public who use their masks when in the bright sunshine andwear sun-glasses or are required to wear eyeglasses to drive or ride ina vehicle will exhale warm, moist air through a cloth mask and quicklylearn that their eyeglasses will fog up and cause them to lose sight.Some face masks are designed to provide for wire (small gauge aluminumor copper wire, for example, inserted at the lateral top edge of a mask;some have shaped sponges for shields, for example, around the nose).These may require manipulation to avoid discomfort or escape of airtoward the eyes (and so protect against foggy eyeglasses).

Many people fail to use proper masks and choose to use handkerchiefs orscarves tied behind their feces which may permit air into openings, forexample, when simply tied behind one's neck and receive air, forexample, or pathogens from an opening under one's chin. On the otherhand, the elastic used in forcing a pre-structured oxygen or ventilatormask of hardened rubber or plastic to cover the many different shapes offeces (everyone's face is differently shaped from one another) can causefacial damage and still be ineffective in covering gaps in an effort tocover one's mouth and nose. If one's mask does not fit properly, onewill be constantly adjusting the mask and may touch their face exposingthem to a viral infection having touched their face. These masks mayhave strong elastic ties to one's ears or around the head. When onewears such a mask for a long period of time, the elastic strength maycause irritation, rashes, markings and general discomfort around itsedges.

Wearing face masks are now an important part of our everyday lives.However, wearing face masks for long periods of time can cause skinissues and irritation. Dermatologists studying the issue of lengthy use,for example, the same mask all day, will irritate facial skin, clogpores, cause acne, rosacea and dermatitis. Also, healthcare workers areunder a lot of stress as they go about their daily duties of, forexample, intubation, inserting oxygen tubes into a nose of a Covid-19patient, or the stress of an operating room or an intensive care unit.

An N95 mask tightened onto the face puts all the pressure of, forexample, a pair strong elastic or rubber straps for tying the mask tothe ears or the back of the head onto the soft facial tissue that is incontact with the mask's edge, especially a mask made of hard rubber orplastic. Researchers have calculated that the resulting pressure frommedical masks can be greater than an equivalent of three pounds persquare inch on the face's soft tissue. A medical worker wearing such amask all day will likely suffer from the edges of the mask and may wantto be careful about choosing the shape of a mask for a twelve-hourshift.

Overly dry skin can lead to skin inflammation due to cracks and fissureswhile facial skin may sweat and masks may be used in humid conditionsand so one's skin may be susceptible to irritation. A moisturizing creammay help some with dry skin but a moisturizing cream is not designed toprevent air from leaking from edges of a face mask.

U.S. Pat. No. 9,963,611 (the '611 patent) to Stewart et al. describes acomposition (for example, of multiple layers of different types ofcloth) and at least two different masks. One type of mask is seen inFIG. 1, FIG. 2 and FIG. 13 of the '611 patent for use as a face mask toshield against viral pathogens. The mask may comprise lateral edge andlooped with a loop extension from the lateral edges to wearing on one'sears. A top edge protects the nasal area while a larger body protectsthe mouth and nose.

A second embodiment of a type of facial mask is shown in FIGS. 3 and 4of the '611 patent (with a resilient member that may be a foam ordeformable strip adjusted by the wearer and flap for contour about thenose), comprising as seen in FIGS. 5,6, 7 and especially FIG. 8 how themask may comprise a flap and sides that may be stitched together toprotect the face with users having to manipulate the mask to excludepathogens from reaching the nose and mouth. As seen in FIGS. 9 through12 of U.S. Pat. No. 9,963,611 of Stewart et al., the mask may compriseas many as four or more layers of different absorbent materials, atleast one layer for capturing and bonding to pathogens. FIGS. 1 and 2show typical disposable face masks with loops 14 to tie the face mask toone's ears. Lateral edges 30 have a perpendicular connection to a topedge and bottom body 12. On the other hand, FIGS. 3-8 show a mask whichhas lateral edges which are more adaptable to being protected andinclude a flap 104 and a resilient member 142 for fitting above the nosebridge.

Prior art FIG. 1 of the present patent application shows a woman wearinga typical oxygen face mask comprising a plastic nose and mouth covering100. The lateral edge of the plastic covering 100 is hard and may damagethe face. The figure appears to show the use of an elastic band whichsurrounds the rear of her head above her ears and may help to lift andhold the tube attached to the mask which serves as an oxygen supplementto air. There is a plastic lateral edge 125 which being held to the faceby elastic can cause discomfort. There also appears to be a hardenedplastic nose bridge contoured to prevent oxygen from escaping to reachher eyes.

Prior art FIG. 2 shows a patient lying in a bed wearing a ventilatormask 200 which appears to comprise plastic or a hardened medicalsilicone. Like the oxygen mask 100, the ventilator mask 200 appears tohave a hardened plastic or silicone lateral edge 225 held by elasticbands to the face of the male patient. Also, it appears from the drawingthat the patient is in discomfort and may have puffy cheeks caused bylong term use of the ventilator mask 200. The oxygen appears to bedelivered by a tube directly to the nasal area of the patient.

Prior art FIG. 3 shows the exterior of a typical 3M N95 rated mask 300typically worn by healthcare workers. The lateral edges 320 are made ofcloth material and appear to be held to the face by pairs of elasticstraps. Healthcare workers may wear their masks for twelve hour shifts.After twelve hours, there may be considerable discomfort from wearingthe mask. Also, the cloth lateral edges 320 may capture air oninhalation and release air on exhalation. A healthcare worker may have aneed to adjust the mask frequently due to the use of the cloth tosnuggly fit over the nose and mouth.

Prior art FIG. 4 shows the interior of the 3M N95 rated mask 400. Theinterior includes a breathing grid 415 and also includes a foam rubbernose bridge 410. The foam rubber nose bridge 410 may cause somediscomfort from a wearer's moving their head especially over a twelvehour shift period.

From measuring the circumference of lateral edges of prior art facemasks of the prior art types described above, the circumferences ofprior art masks all appear to be approximately the same. As will bediscussed below, the similar circumferences may be utilized to advantagein the present invention.

There remains in the art a need to solve the problems caused by the useof sharp-edged plastics, cloths, silicone and rubber materials for aface mask with elastic rubber or string ties to the ears or surroundingthe head that can cause considerable discomfort, even some forms ofdisease and sores to develop that cannot be treated with moisturizingcream alone or the use of deformable strips, resilient members and wiresembedded in edges of cloth face masks, surgical masks or oxygen masks orventilators.

SUMMARY OF THE EMBODIMENTS

The present invention solves the comfort and protection problems ofprior art face mask designs. An embodiment of the face mask protectionis designed to comprise a U-shaped member (or one that is semi-circularor almost circular) and a soft gel type material such as a medicalsilicone (Shore A0 on the hardness scale) that may be fixed to thelateral edges of a face mask that may or may not contain deformablewires that a user may shape to the contours of their face or nose. Frominvestigation, it has been determined as indicated above that most facemasks have the same or similar circumference (for example, the length ofthe cloth material comprising the lateral edges of a 3M N95 face maskshown in prior art FIGS. 3 and 4). A medical grade silicone is selectedaccording to a Shore hardness scale to be deformable but tight enough soas to fit permanently around the lateral edges of most face masks suchas a Shore A hardness scale between 10 and 40, preferably approximately25. An outer shell may contain the medical soft gel material and whencoated on the inside with a petroleum jelly or Shore A 0 gel or jellywill wet or protect any exterior cloth lateral edges. Of importance,also, is the coating on the interior of the U-shaped or circular memberwith a soft medical silicone gel or petroleum jelly so that the soft gelserves at least two purposes. A first purpose is to wet or renderleak-proof a lateral edge, for example, comprising cloth to preventleakage of airborne pathogens to the facial area. Ideally, a face maskshould not be moved once applied to the face. The movement may alleviatediscomfort but cause leakage of airborne pathogens to the face. A secondpurpose is comfort. When a U-channel, circular or clasping soft cushioncovering covers the lateral edges, any discomfort brought on by use ofelastic straps or string ties with movement of the face and head may bealleviated.

Special provisions may be used in the nasal area to provide a protectionof nasal exhalations from rising upward toward the eyes of the wearer,especially to prevent fogging of eyeglasses. While foam rubber is knownused in N95 masks and a nose plate is known from the oxygen andventilator masks of FIGS. 1 and 2, these can be uncomfortable andreplaced by deformable nose bridges coated with petroleum jelly ormedical 0 hardness silicone gel. The coating also should also preventthe wearer from suffering any long-term adverse reactions to the coatingand be medically safe.

These and other features of the present invention will be made clearfrom the Brief Description of the Drawings which follows along with theDetailed Description which follows the brief description.

BRIEF DESCRIPTION OF THE DRAWINGS

A convention is used with the drawings of the present invention suchthat the first number of a reference numeral such as 100 represents thefigure number of the item where a particular component 10X first appearswhere X is intended to comprise a similar component in a later discussedfigure.

FIG. 1 shows an example of a prior art oxygen face mask 100 having alateral edge 125 that appears to comprise plastic that can beelastically tied to the face. The pressure caused by the elastic ormaterial ties around the head may cause discomfort in the regions of theface protected by lateral edges 125. The oxygen face mask 100, beingsolid, may not fit the wearer such that oxygen leakage is avoided.

FIG. 2 shows a prior art ventilator face mask 200 which may alsocomprise a solid plastic lateral edge 225 that may rub against the skinand irritate the facial regions where the lateral edges 225 are pulledtight or even cause some forms of disease. The purpose of the ventilatoris to deliver and potentially force air into the lungs for a personhaving difficulty breathing. Adjustable elastic straps may hold the maskto one's face, but the patient may be forced to rest in one position inorder to safely and comfortably wear this ventilator mask.

FIG. 3 shows a front view 300 of a 3M N95 rated face mask. Of importanceis the circumference of the face mask comprising a flexible border softmaterial (lateral edge 320) which may allow leakage of air to the noseand fails to form a tight seal against leakage of viral pathogens to theexterior, less). A nose grid 315 comprises a filter for the mask and themask is especially recommended for healthcare workers.

FIG. 4 shows a rear view 400 of the 3M N95 rated face mask example facemask 300 of FIG. 3. Notice that there is a grid 415 (the opposite sideof grid/filter 315 of FIG. 3) for receiving air from the exterior,filtering the inhaled air and emitting breathed air to the exterior. Inaddition, a foam rubber nose bridge 410 may be formed to preventbreathed air from rising above the nose to the eyes of the wearer. Thefoam nose bridge 410 may or may not effectively prevent a wearer of theface mask who wears eye glasses from having their glasses fog.

FIG. 5A shows a cross-section 500 of a U-shaped or semi-circular shapedexterior shell of apparatus for surrounding the lateral edges of a facemask, for example, face masks 100, 200, 300 and 400 of prior art FIGS.1,2,3 and 4. In one embodiment, the exterior shell 501 has asemi-circular or U-shaped cross-section which will be discussed withrespect to prototype FIG. 10. Other useful shapes are a clam or claspingshape (like a clam shell). Inside the exterior shell 501, the shellpreferably contains a soft gel, jelly or petroleum jelly 502 which ismalleable and in combination with the shell 501 may be used to clasp thelateral edges of, for example, the entire circumference of an N95 facemask. Reference numerals 504, 505 are A and B ends intended to showinsertion of soft silicone medical grade gel into shell 501. Referencenumeral 506 may represent that the cross-section 504 or 506 may betapered, molded, plugged or clasped together and to a cloth materialsuch as the lateral edges of an N95 cloth mask. As will be discussedwith reference to FIG. 10, a continuous circle of cross-section 504 maybe manipulated by the user to coat the interior with petroleum jelly orsoft silicone gel so as to wet the N95 cloth lateral edges.

FIG. 5B is an expanded view of a Shore A-00 hardness scale and examplesof uses of silicone for a substance such as a soft gel or jelly-likesubstance that may be used as a coating or a filler from “extra soft” tohard. Silicone in the lower hardness numbers such as 10-40 may haveelastic qualities allowing the silicone to be stretched and manuallycoated inside and out to protect the face and to grasp the lateral edgesof the face mask.

FIG. 6 show's a detailed cross-section example of a typical interior ofan N95 face mask 600 fitted with a U-shaped or semi-circular shaped orcircular shaped shell 601 (shown in cross-section) which clasps clothlateral edge material of the N95 mask (not shown). Interior soft gel 602serves to moistens the fabric or cloth of lateral edges of the N95 maskand exterior soft gel 602 wetting the cloth material lateral edgesprevents air leakage and while exterior soft gel 602 coating the shell601 promotes a comfortable fit to the face. Nose bridge 610 is shown asin FIG. 4 comprising foam rubber but may be coated with petroleum jellyor soft gel 602.

FIG. 7 provides further details of the present invention than FIG. 6 andshows a foam nose bridge of foam 410 of FIG. 4 adapted to be clasped bya nose bridge comprising shell silicone gel 701 and containing siliconegel 702. Reference numeral 703 indicates that a soft silicone edgecushion may replace prior art foam rubber as a nose bridge on the top ofa wearer's nose (for example, a clasping shell 701 that clasps theexistent foam rubber for comfort and to protect against air leakage tothe eyes on exhalation).

FIG. 8 provides the interior details 800 of an N95 face mask utilizingthe present invention. The mouth and nose grid 415 of FIG. 4 has beenremoved. A U-shaped, semi-circular or mostly circular exterior shell 830has been carefully fitted around the lateral edges of the face mask 800such that the lateral edges have been fitted into the shell and coating830. Note that the shell 830 is continuous and of predetermined length,is elastic and so can fit around the N95 mask lateral edges and helpshape the N95 mask. Also, the foam rubber nose bridge has been replacedwith a nose bridge 825 which is deformable and can conform to the bridgeof the nose of a wearer by lightly pressing on the deformable nosebridge 825. The nose bridge 825 may protect the nose by a wearerapplying a medical silicone gel or petroleum jelly (not shown) to thesurface of the bridge 825 before placing it on the nose and adjustingits form.

FIG. 9 shows a formed cushion for a face mask having the same or asimilar circumference as the lateral edges of an N95 face mask of FIGS.3 and 4. Component 901 is the clasping shell which clasps the lateraledges of a face mask and component 902 is the interior coating which maycoat cloth material and prevent air from escaping from the sides.Reference numeral 907 is intended to represent that the shell 901 andinterior coating 902 are continuous and form a predeterminedcircumference that is elastic medical silicone for protecting thewearer's face and having a coating for preventing against leakage.

FIG. 10A shows a typical face mask 1000 in front view which may be anyof an oxygen mask, a ventilator mask, a disposable face mask or asurgical mask 1000 having been manually fitted around lateral edges ofthe mask 1050. A soft U-shaped medical silicone for clasping the lateraledges of the mask 1030 is continuous and is manually fitted to thelateral edges of the mask 1050.

FIG. 10B shows FIG. 10A in cross-section at a lateral edge of the mask1050 such that the soft U-shaped medical silicone section 1030 claspsthe mask at lateral edge 1050.

Now a detailed description of FIGS. 1-10B will be provided havingbriefly described the present invention.

DETAILED DESCRIPTION

The present invention is directed to a face mask, face and noseprotector that provides greater comfort to the wearer and preventsleakage of exhaled air form the lateral edges of the face mask whichwill be described with reference to FIGS. 1-10B.

FIG. 1 shows an example of a prior art oxygen face mask 100 having alateral edge 125 that appears to comprise plastic. The face mask 100with its surrounding lateral edges 125 can be elastically tied to theface. The pressure caused by the elastic or material ties around thehead may cause discomfort. The oxygen face mask 100 being solid, may notfit the wearer so that the mask is comfortable to wear and such thatoxygen leakage from the lateral edges 125 may be avoided. Notice alsothat there appears to be a nose bridge for preventing a loss of oxygenin the direction of the eyes. As will be discussed herein with referenceto FIGS. 6-1 OB, a soft cushion shell of the present invention providesa soft gel internal to the soft cushion shell that is intended torelieve discomfort and prevent air from escaping from lateral edges of,for example, a face mask comprising an oxygen mask.

If this patient were to wear this mask 100, as is, all day long andnight, with apparently plastic edges, it is highly likely that thepatient will have discomfort. The wearer may develop skin conditionsform wearing the mask for long intervals, perhaps abrasions or evencontusions. It is a feature of the present invention to provide a softcushion shell that fits over the edge and protects the wearers face,adapted to be used with a coating for contacting the mask and a coatingfor contacting the face underneath the shell for clasping the mask toprotect from leakage of oxygen to the air and promote comfort.

FIG. 2 shows a prior art ventilator face mask 200 which may alsocomprise a solid plastic edge 225 that may rub against the skin andirritate the skin. The purpose of the ventilator is to deliver andpotentially force air into the lungs for a person having difficultybreathing. Adjustable elastic straps may hold the mask to one's face.The pressure caused by the elastic or cloth material ties around thehead may cause discomfort where the lateral edges contact the face. Theventilator face mask 200 being made of a solid material such as plastic,may not fit the wearer such that oxygen leakage can be avoided. A softcushion shell may be provided as will be discussed with reference toFIGS. 6-10B comprising a medical silicone shell component that containsa soft gel or jelly that is intended to relieve discomfort and preventair from escaping from lateral edges of, for example, a face maskcomprising an oxygen mask. Also, the shell may be coated with a soft gelor petroleum jelly that alleviate a patient's facial discomfort.

In other words, the ventilator mask shown, appears to be very similar tothe oxygen mask of FIG. 1. The patient appears to exhibit some swellingin his face around the mask 200, perhaps caused by the lateral edges 225which can be avoided by using a soft cushion tubing like structure withsoft gel that can protect the face and prevent oxygen leakage.

FIG. 3 shows a front view 300 of a prior art 3M N95 rated face mask. Ofimportance is the circumference of the face mask comprising a flexibleborder soft cloth material which may allow leakage of air intended to beinhaled by the mouth or nose. The lateral edges 320 form a circumferencethat fails to form a tight seal against leakage of viral pathogens tothe exterior. A filter grid 315 and cloth material is shown which isintended for air or oxygen inhalation and exhalation. The materialforming the mask may be multi-layers so that 95% of small viralpathogens on the order of three microns cannot enter the mask and reachthe patient.

The N95 face mask is most popular for use by healthcare workers inhospitals and wards when they are working closely with diseasedpatients. The cloth material lateral edges may be adapted to receive asoft cushion shell according to the present invention that is elasticand of sufficient circumference to reach around the entire mask. As withFIGS. 1,2, and 3, please refer to FIGS. 6-10B for an explanation of thepresent invention.

FIG. 4 show's a rear view 400 of the 3M N95 rated face mask example facemask 300 of FIG. 3. Notice that there is a grid 415 (the reverse side ofgrid/filter 315) for receiving air from the exterior, filtering theinhaled air and emitting breathed air to the exterior. In addition, afoam nose bridge 410 may be formed to prevent breathed air from risingabove the nose to the eyes of the wearer. The foam rubber nose bridge410 may or may not effectively prevent a wearer of the face mask whowears eyeglasses from having their glasses fog.

According to the present invention as described by FIGS. 6-10B, thelateral edges 420 are sealed by a clasping elastic shell that fits theentire circumference of the lateral edge. Also, the foam rubber bridge,if detrimental to the patient, may be fitted with a nose bridgeconstructed similarly to the protective and wetting shell soft cushion,for example, of medical silicone gel.

FIG. 5A shows a cross-section 500 of a U-shaped or semi-circular shapedexterior shell of apparatus for surrounding the lateral edges of a facemask, for example, N95 face masks 300 and 400 of FIGS. 3 and 4. In oneembodiment, the exterior shell has a semi-circular or U-shapedcross-section which will be discussed with respect to prototype FIGS.10A and 10B. Inside the exterior shell coating 501, for example, ofShore A extra soft hardness 10-40 (see FIG. 5B for a Shore A hardnessscale), the shell preferably contains a soft gel 502 which is malleableand in combination with the shell 501 is used the clasp the lateraledges of, for example, the entire circumference of an N95 face mask,oxygen mask or ventilator mask (or surgical mask, not shown). See FIGS.10A and 10B. Reference numeral 504, an A end, for fitting to a B end 505is intended to indicate ends of a shell 501 that are formed to meet oneanother during injection molding in one embodiment that is made just forone common mask. In another mode of manufacture, by using a plug, bytapering one end to fit into the other or other means, a measured lengthof U-channel may be fitted to fit the lateral edge of any face mask. Forexample, an A end may fit into a pocket formed in the B end to receivethe A end such that a typical circumference of a lateral edge of a facemask may be covered by the shell clasping the lateral edges having beenhand-fitted around the mask to match its circumference. See FIGS. 10Aand 10B.

One of many known injection molding processes may be used for forming acomplete unit for fitting a given mask or for making a self-installablesized mask that may have A and B ends for plugging into one another.During injection molding processes, the cushion around a face mask maybe manufactured as a complete circumference designed to fit a particularmask such as an N95 mask having a predetermined circumference of lateraledging. Per FIG. 5, when injection molding is used to process the softgel part 502, 505 of the cushion, the gel part 505 may be inserted intothe cushion. Alternatively, the A end 504 of U-channel, semi-circularcushion having length 506 may be tapered to fit in the B-end 505.Outside air cannot enter the U-shaped channel. Also, air or water may beinserted into the U-channel 501 in place of soft gel or other similarmaterial. Component 502 may be an extra soft gel or jelly material of aShore A hardness of extra soft or in the range of 0 to 10 if comprisedof medical silicone quality gel. As will be further described herein,the internal material 502 may be air or water. Reference numeral 505 isintended to show the insertion of soft gel 502 within the shell 501.Length 506 is intended to be the typical circumference of a face mask.From measuring the circumference of various types of face masks, it hasbeen determined that most face masks have the same overallcircumference. In other words, one size soft cushion will fit most facemasks.

FIG. 5B shows a Shore hardness scale used by manufacturers of medicalsilicone gel to qualify the hardness of silicone material. The Shorehardness is intended to be between 00 A and 40 A of a durometer scalefor both soft gel or a jelly like substance interior and a hardnessbetween a range of 10-40 on the extra soft Shore A Hardness scale forthe exterior shell like clasping component 501. Preferably, the shell501 will have a greater Shore hardness that is harder than the soft gelinterior or coating 502 so that is elastic and formable as it covers thelateral edges of a face mask of any type.

FIG. 6 shows a detailed cross-section example of a typical interior ofan N95 face mask fitted with a U-shaped or semi-circular shaped orcircular shaped shell 601 which is elastic but may clasp cloth lateraledge material (not shown in this figure). Interior soft gel 602 may beused on the exterior to moisten fabric of lateral edges, prevent airleakage and promote a comfortable fit to the face. Interior gel 602 mayalternatively comprise water or air or other medically sale liquid orgas. Nose bridge 610 is shown as in FIG. 4 comprising foam rubber thatmay be clasped by, for example, a U-shaped cross-section 601, 602 andcoated on its exterior with soft gel or petroleum jelly (or othermedically safe lubricant) to seal the nose bridge and be expected to bemore comfortable and tighter fitting than an N95 foam rubber nosebridge.

FIG. 7 shows another example of an N95 face mask and provides furtherdetails of the present invention than FIG. 6, particularly regarding anose bridge having an average length 703. FIG. 7 shows a foam nosebridge of foam 410 of FIG. 4 covered by and adapted to be clasped by anose bridge comprising shell silicone gel 701 and containing siliconegel 702. The nose bridge 701, 702 need not be elastic as it is assumedto be of the same length as foam rubber bridge 410 of FIG. 4. Theadditional nose bridge 701, 702 of triangular length 703 may be coatedwith soft medical grade soft gel or petroleum jelly to seal the nosebridge and protect the wearer's nose from damage from rubbing foamrubber. Grid/filter 715 is shown and car loops are shown for holding theN95 mask to the ears of a wearer.

FIG. 8 provides the interior details of an N95 face mask prototype 800utilizing fee present invention. The mouth and nose grid 415 has beenremoved. Elastic bands (which may be uncomfortable) are shown for theears and to fit around the neck. A U-shaped, semi-circular or mostlycircular exterior shell 830 has been carefully fitted (because it iselastic and of similar circumference) around the lateral edges of theface mask 800. Also, the foam rubber nose bridge of the N95, in thisembodiment, has been replaced with a nose bridge 825 which is deformableand can conform to the bridge of the nose of a wearer by lightlypressing on the deformable nose bridge 825 to deform it to the shape ofthe wearers nose. The nose bridge 825 may protect the nose by applying amedical silicone gel (not shown) to the surface of the bridge 825 beforeplacing it on the nose and adjusting its form. Also, the nose bridge 825may be adapted to clasp the foam rubber nose bridge equipped with theN95 mask interior (see FIGS. 6 and 7) but adapted in size for theindividual wearer (who may have a larger nose than most wearers).

Per FIG. 8, a wearer may self-install a cushion of FIG. 5 around thelateral edges of a given face mask that has a lateral edge of adifferent circumference than a well-known mask such as the N95. Alengthy piece of U-channel or semicircular tubing having A and B endsper FIG. 5 may use a juncture point 835 such as a plug (not shown) toplug one end to the other having cut the cushion of FIG. 5 to fit. Oneof the A end or B end may be tapered to fit into each other. A wearerwould have to cut the cushion to fit cutting the end that is not taperedor for use of a plug or other device to join the ends of the cushion.

Also, per FIGS. 5, 6, 7 and 8, the cushion of the invention may have gelinserted or no gel inserted. Air or water may be used in place of softgel filler 502, 505. Referring to FIG. 10, air or water or soft gel maybe used as the filler of the U-channel opening 1005.

FIG. 9 shows a formed soft cushion 900 in a circumferential or somewhatcircular shape for a face mask having the same or a similarcircumference as the lateral edges of an N95 face mask of FIGS. 3 and 4.Component 901 is the clasping shell which clasps the lateral edges of aface mask and 902 is the interior coating which may be used to make theshell more formable and may be used to coat cloth material and preventair from escaping from the sides. Component reference numerals 907 areintended to point to a clasped lateral edge of, for example, an N95 orother face mask.

FIG. 10A and FIG. 10B are intended to be considered together where FIG.10A is a front view of a face mask 1000 and FIG. 10B is a cross-sectiontaken from cylinder 1075 of FIG. 10A which have arrows pointing tocross-section FIG. 10B. The face mask 1000 of FIG. 10A has acircumferential embodiment of a soft U-shaped medical silicone tube-likestructure 1030 for clasping the lateral edges of any face mask ofsimilar circumference. The structure 1030 may be manipulated by hand toclasp the lateral edges of a face mask and have an interior 1005 asdiscussed above. Its exterior may be coated or the lateral edges of theface mask may be wetted with extra soft silicone hardness 0 to 10,petroleum jelly or other soft jelly-like substance to prevent air fromleaking from the mask where shell 1030 clasps a face mask lateral edge1050. Gel or jelly like substance 1005 is seen interior to claspingU-shaped shell 1030 (or air or water may be used as discussed above).FIG. 10B is a cross-section 1075 or a preferred embodiment comprising aclasping shell 1030 for clasping a lateral edge 1050 of a face mask. Thesame wet extra soft gel or jelly 1005 may be used to coat the interiorof the shell 1030 where it clasps the lateral edge 1050.

A method of manufacture of a soft shell cushion apparatus as shown inFIGS. 10A and 10B may comprise injection molding. The apparatus 1030containing a soft gel or other material (or air) in the length of tubingshown as cross-section 1005 may forming a self-installable fit to a facemask comprising the following steps of manufacture. One first forms aU-shaped channel of predetermined length of medical grade siliconehaving an extra soft Shore A Hardness scale value between 10 and 40, thepredetermined length being measured by measuring a circumference oflateral edges of an N95 face mask. Then the U-shaped channel is filledwith medical grade silicone having an extra soft Shore A Hardness scalevalue between 0 and 10, the silicone completely filling the length ofU-shaped channel for air or water). A final step is using injectionmolding processes to manufacture a cushion for fitting a particular maskof predetermined lateral edge circumference. In an alternative method,the A and B ends of a shell 1030 may be tapered or fitted together witha plug for scaling A and B ends of the U-shaped channel by joining oneend to the other after the filling step. Use of one of heat and bondingmaterial may be applied to the A and B ends (if the shell 1030 is notmade in one piece) to join the ends together to comprise a scaled loop.

Other variations of the embodiment of FIG. 10A or 10B may come to mindby careful consideration of the depicted embodiments. Improvements toshape and elasticity may come to mind of one of ordinary skill to fitthe cushion apparatus to the plastic of an oxygen or ventilator mask, toa surgical mask or to an N95 face mask to improve comfort and preventescape of air or oxygen above the nose.

Further, the purpose of the foregoing Abstract is to enable the U.S.Patent and Trademark Office and the public generally and especially thescientists, engineers and practitioners in the relevant art(s) who arenot familiar with patent or legal terms or phraseology, to determinequickly from a cursory inspection the nature and essence of thistechnical disclosure. The Abstract is not intended to be limiting as tothe scope of the present invention in any way which should be limitedonly by the claims which follows.

What is claimed is:
 1. A soft shell cushion apparatus for use with aface mask having lateral edges totaling a predetermined circumference,the soft shell cushion apparatus comprising: said soft shell cushionapparatus configured to clasp said lateral edges of said face mask, saidface mask and said soft shell cushion apparatus configured to clasp saidlateral edges of said face mask, said soft shell cushion apparatus beingmanipulated by hand to clasp said lateral edges of said face mask; saidsoft shell cushion apparatus comprising a soft medical silicone shellhaving a U-shape cross-section, the U-shape cross-section having a firstopen interior end having a clasping shell shape adapted for claspingsaid lateral edges of said face mask and a second closed interior endhaving an aperture containing one of a soft medical silicone gel, jelly,air and water, said second closed interior end containing said one ofsaid soft medical gel, jelly, air and water such that said one of softmedical cushion gel, jelly, air and water permits said hand manipulationof said open interior end adapted for clasping said lateral edges ofsaid face mask; said soft shell cushion apparatus for promoting comfortto a wearer of said face mask equipped with said soft shell cushionapparatus and for preventing the lateral edges of said face mask fromleaking air to an exterior of said face mask.